Office of Regulatory Compliance

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Two committees oversee clinical research within UCLA's Jonsson Comprehensive Cancer Center (JCCC), the Internal Scientific Peer Review Committee and Data Safety Monitoring Board. Proper conduct of clinical trials in oncology is ensured by the Internal Quality Assurance Program, established in 1986.

Internal Scientific Peer Review Committee

The Internal Scientific Peer Review Committee (ISPRC) reviews clinical oncology protocols conducted by JCCC investigators. Drs. John Glaspy and Albert Lai serve as Co-Chairmen of the ISPRC. Under their direction, the committee reviews the required elements of the clinical protocol, statistical applications and other factors such as adequate research staffing, any competing trials, well-constituted data collection forms and utilization of other JCCC resources.

ISPRC application forms are available for download below. Only electronic submissions are accepted.

ISPRC meetings are held every other Tuesday. The deadline for submissions is every Tuesday at 5:00 p.m. PST, for the following Tuesday’s meeting.

Data Safety Monitoring Board

In response to the National Cancer Institute mandate, the JCCC Data Safety Monitoring Board (DSMB) was constituted in January 2001 and meets monthly. The JCCC DSMB reviews all Serious Adverse Events (SAEs) occurring in JCCC protocols. In addition, the JCCC DSMB serves as the DSMB for institutional research studies at UCLA that do not have an external DSMB.

The JCCC DSMB helps to ensure that adequate safety monitoring will be carried out for all cancer interventional trials offered at the JCCC. The DSMB oversees the implementation of the data monitoring plans approved by ISPRC and on file with the JCCC. The chairman of the JCCC DSMB is Dr. Sven De Vos.

Internal Quality Assurance Program

JCCC has had a long-standing Internal Quality Assurance Program (IQAP), beginning in 1986, to ensure proper conduct of clinical trials in oncology and, in so doing, safeguarding the rights and welfare of the study subjects. The internal compliance program is responsible for establishing an effective mechanism to promote proper adherence to all applicable local, state and federal laws, as well as specific program or cooperative group requirements by all researchers involved in oncology clinical research.

The IQAP includes:

  • Performance of prospective monitoring and retrospective auditing of active trials to ensure regulatory and protocol compliance
  • Ensuring proper patient management per protocol and to ensure patient safety
  • Assisting principal investigators, sub-investigators and all clinical trial study team members by consulting on problems identified during any monitoring or auditing reviews
  • Educating and continually updating the research community regarding clinical research requirements

Submissions

Please submit all applications to the Office of Regulatory Compliance via email (submission link). Only electronic submissions are accepted.

Office Location

UCLA's Jonsson Comprehensive Cancer Center
Office of Regulatory Compliance
1001 Gayley Avenue
Suite 200, Room 13
Los Angeles, CA 90024
Mail Code: 735207

Contact Information

Main Office
Phone: (310) 794-8742
Fax: (310) 794-8772

Augustine Fernandes
Administrative Director, JCCC ORC
(310) 206-5775

Mark Glover
Regulatory Affairs Reporting Coordinator
(310) 794-8742

Allan Udarbe
Compliance Officer
(310) 794-5218

Andrew Deur
Public Administration Analyst
(310) 794-1852

Monica Vaughn
Public Administration Analyst
(310) 825-3482